An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-small Cell Lung Cancer (TEAM)

Roche

Status: Completed

Conditions: Nonsquamous Nonsmall Cell Neoplasm of Lung

Treatments: Drug: Erlotinib

Study type: Observational

Funder types: Industry

Identifiers

NCT01161173

ML21474

Details and patient eligibility

About

This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second-line treatment in patients with recurrent or metastatic non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1 course of standard systemic chemotherapy, experienced disease progression, and who are receiveingTarceva in a second-line setting. Patients will also be followed through third-line treatment if there is disease progression on Tarceva therapy.

Enrollment: 347 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients ≥ 18 years of age.
• Written informed consent.
• Recurrent or metastatic, Stage III or IV non-small cell lung cancer (NSCLC).
• Measurable disease (Response Evaluation Criteria In Solid Tumors).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Prior course of standard systemic chemotherapy.

Exclusion criteria

• Contra-indications to treatment with Tarceva.

Trial design

347 participants in 1 patient group

Erlotinib

Description:

Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.

Treatment:

Drug: Erlotinib